LFXClass II
Enzyme Linked Immunoabsorbent Assay, Rubella
21 CFR 866.3510 / Microbiology
LFX is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Rubella, a class II device type, regulated under 21 CFR 866.3510. As of , FDA records hold 94 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- LFX
- Device name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Regulation
- 21 CFR 866.3510
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 94
- Ingested recalls
- 15
Clearances, product code LFX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 6 |
| 1987 | 5 |
| 1988 | 5 |
| 1989 | 17 |
| 1990 | 7 |
| 1991 | 3 |
| 1992 | 6 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 9 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 3 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2025 | 2 |
Applicants with the most clearances
Product code LFX| Applicant | Clearances |
|---|---|
| Abbott Medical | 8 |
| Siemens Healthcare Diagnostics Inc. | 5 |
| Diamedix Corp. | 5 |
| Gull Laboratories, Inc. | 5 |
| Labsystems, Inc. | 5 |
| Ortho Diagnostic Systems, Inc. | 5 |
| Zeus Scientific LLC | 5 |
| Diasorin Inc. | 3 |
| Disease Detection International, Inc. | 3 |
| General Biometrics, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.